Problems of Forensic Sciences 2000 Vol. 43 (XLIII) 70-78
VALIDATION AND QUALITY ASSURANCE OF A BROAD SCALE GAS CHROMATOGRAPHIC SCREENING METHOD FOR DRUGS
Merja GERGOV, Jari NOKUA, Ilpo RASANEN, Ilkka OJANPERÄ
Department of Forensic Medicine, University of Helsinki, Helsinki, Finland
Streszczenie
Validation and quality assurance procedures are described for a gas chromatographic screening method for 104 basic drugs in blood. The instrument validation included repeatability of injection, retention times, retention indices and peak areas. The validation of quantitative measurements consisted of linearity, accuracy, intra-assay precision, limits of quantitation and estimation of the uncertainty of measurement. In quality assurance, preventive maintenance of the instrument, calibration and internal and external quality controlwere performed regularly. The method was accredited by Finnish Accreditation Service (FINAS) in 1997.
Słowa kluczowe
Validation; Quality assurance; Gas chromatography; Drug screening.